Transcript LEGALITIES OF THE VETERINARY USE OF DRUGS IN HORSES

LEGISLATION, REGISTRATION AND CONTROL
PROCEDURES FOR VETERINARY MEDICINAL
PRODUCTS IN SOUTH AFRICA
Dr R D Sykes
DAKAR
Senegal
2008
Medicines and Related Substances Control Act
(Act 101/1965)
Medicines
CONTROLS
Veterinary and Paraveterinary Professions Act
(Act 19/82)
CONTROL ACTS
Pharmacy Act
(Act 53/1974)
Foodstuffs, Cosmetics and Disinfectants Act
(Act 54/1972)
Fertilizer, Farm Feeds, Agriculture and Stock
Remedies Act
(Act 36/1947)
REGISTRATION
SAFETY
Stock Remedies
Veterinary Medicines
•NEW MOLUCULE
•TOXICITY
•GENERIC
•TARGET ANIMALS
•NEW FORMULA
•RESIDUES
ENVIRONMENTAL
ENVIRONMENTAL SAFETY
• Diclofenac
• Gamma-BHC
EFFICACY
Stock Remedies
Veterinary Medicines
•PRECLINICAL
•CLINICAL
•LOCAL
QUALITY
•SOURCE OF ACTIVE
•PACKAGING
•FORMULA
•STABILITY
•MANUFACTURE
WHO – WHERE – HOW
QUALITY
LABORATORIES
• Vaccine Laboratory
• MCC Laboratory
• Industrial Laboratories
GMP – Testing
Inspections
GOOD MANUFACTURING PRACTICE
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INTERNATIONALLY RECOGNISED
REGULATION COMPLIANT
SUBJECT TO AUDIT
CURRENT CERTIFICATE
– cGMP
Criteria for establishing
stock remedy status
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Drugs for readily diagnosable stock diseases
Prophylactic substances
Production enhancing substances
Commodity animal substances
Safety of product
Requirements for supply
of stock remedies
• No deviations from requirements and
instructions as indicated on label
• Veterinarian may make own
recommendation
• May only be sold in original pack
Requirements for supply of stock
remedies
•Any condition of sale
•“For use by or under the control of a
veterinarian only”
STOCK REMEDIES
• ECTOPARASITICIDES
• ANTHELMINTICS
• ANTI-MICROBIALS
– MASTITIS REMEDIES
– ARTHROPOD BORNE DISEASES
– PRODUCTION ENHANCERS
Criteria for establishing
POM status
• Substances controlled by conventions
• Requirements for special precautions
regarding safety
• Handling requirements
• Necessity for precise diagnosis or
therapeutic measures
• POM for human use
VEERINARY MEDICINES
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ANTIBIOTICS
HORMONES
ANTI-INFLAMMATORIES
ANAESTHETICS
TRANQUILISORS
Definition of sale
Means sell by wholesale or retail and includes
import, offer, advertise, keep, expose, transmit,
consign, convey or deliver for sale or authorise,
direct or allow sale or prepare or possess for
purpose of sale, and barter or exchange or supply
or dispose of to any person whether for a
consideration or otherwise; and sell, sale and
sold have corresponding meanings.”
CONTROL
NO STOCK REMEDY OR VETERINARY
MEDICINE MAY BE SOLD UNLESS IT
IS REGISTERED
IMSPECTORATE
SEAVDRAC
NEEDS
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Food security
Unique diseases and parasites
Information on drug source, supply and quality
Access to international evaluations applicable to local
conditions
• Ecotoxicological information to protect local biodiversity
• Post-registration control and use monitoring.
– Inadequate administrative structures
– Vague or inadequate lines of authority
– Duplication of functions
SEAVDRAC
PROBLEMS
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Political differences between countries
Political problems within countries
Ignorance
Communication difficulties
Exploitation
– Dumping
– Counterfeit products
• Financial constraints
• Infrastructure
THANK YOU
DUKE